BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATERIALISE PERSONALIZED SOLUTION

    MDR report key: 19376849 · Received May 22, 2024

    Report

    Report Number
    3005718816-2024-00001
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 28, 2024
    Manufacturer
    MATERIALISE USA, LLC
    Product Code
    PBF
    UDI-DI
    05420060343261
    PMA / PMN Number
    K112389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION, IT WAS FOUND THAT DESIGN AND PLANNING STEPS WERE DONE ACCORDING TO SPECIFICATIONS. DUE TO THE COMPLEXITY OF THE SURGERY SEVERAL CLINICAL ASSUMPTIONS WERE MADE DURING THE PRE-OPERATIVE PLANNING. SURGEON CONFIRMED THAT THE ULNAR VARIANCE AFTER SURGERY WAS NEUTRAL, BUT DURING FOLLOW-UP, THE PATIENT PROGRESSED TO AN ULNA +. THE SURGEON DOES NOT EXPECT LONGITUDINAL INSTABILITY BECAUSE THE RADIUS DOES NOT SEEM TO BE MIGRATED PROXIMALLY.

    Additional Manufacturer Narrative · 0

    ON 3/26/2024 SURGEON INFORMED MATERIALISE THAT PATIENTS ULNA WAS 1CM POSITIVE AFTER THE CORRECTION WAS FINISHED. HOWEVER, INFORMATION WAS NOT COMPLETE AND ON APRIL 28TH NEW INFORMATION WAS OBTAINED THAT INDICATED THE OCCURENCE OF AN ADVERSE EVENT WITH THE PATIENT THE INVESTIGATION IS ON GOING

    Description of Event or Problem · 0

    PATIENTS ULNA WAS 1CM POSITIVE AFTER THE CORRECTION WAS FINISHED.

    Description of Event or Problem · 0

    PATIENTS ULNA WAS 1CM POSITIVE AFTER THE CORRECTION WAS FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994363 MATERIALISE PERSONALIZED SOLUTION RADIUS/ULNA OSTEOTOMY GUIDE AND MODEL PBF MATERIALISE USA, LLC O-01-0-101000-0011-010 OO23CARGAF 05420060343261

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Other